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Neoadjuvant befotertinib plus vorolanib in resectable stage II–IIIB EGFR-mutant NSCLC: a study protocol for the prospective, single-arm phase I/II trial

   
@article{TLCR119197,
	author = {Leilei Wu and Lei Cai and Da Chen and Sheng Chen and Xiancong Huang and Qiqi Yang and Jinshi Liu and Qixun Chen and Xun Yang and Qiang Zhao and Taobo Luo and Jian Zeng},
	title = {Neoadjuvant befotertinib plus vorolanib in resectable stage II–IIIB EGFR-mutant NSCLC: a study protocol for the prospective, single-arm phase I/II trial},
	journal = {Translational Lung Cancer Research},
	volume = {15},
	number = {7},
	year = {2026},
	keywords = {},
	abstract = {Background: Neoadjuvant targeted therapy is a promising strategy for resectable non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation, but pathological regression remains suboptimal with EGFR-tyrosine kinase inhibitor (TKI) monotherapy. Befotertinib is a third-generation EGFR-TKI, whereas vorolanib is a multi-target antiangiogenic TKI. Combined EGFR and vascular endothelial growth factor receptor (VEGFR) pathway inhibition may enhance tumor regression while preserving surgical feasibility.Methods: This is a prospective, open-label, single-arm phase I/II study enrolling NSCLC patients with clinically resectable stage II–IIIB harboring sensitizing EGFR exon 19 deletion and/or exon 21 L858R mutations. Phase I uses a 3+3 dose-escalation design to determine the maximum tolerated dose and recommended phase II dose of neoadjuvant befotertinib plus vorolanib. Phase II adopts a two-stage design and evaluates major pathological response after two 21-day neoadjuvant cycles. Patients undergo radiographic assessment after neoadjuvant therapy, followed by radical surgery 4–6 weeks after the last treatment dose. Secondary endpoints include pathological complete response, R0 resection rate, objective response rate, disease control rate, safety, disease-free survival, and overall survival.Discussion: This trial will prospectively explore the feasibility, safety, and preliminary activity of combined third-generation EGFR inhibition and antiangiogenic therapy in resectable stage II–IIIB EGFR-mutant NSCLC. The study may help define whether intensification of neoadjuvant targeted therapy can improve pathological regression in this molecularly selected population.Trial Registration: Chinese Clinical Trial Registry (ChiCTR2500103324).},
	issn = {2226-4477},	url = {https://tlcr.amegroups.org/article/view/119197}
}